Abstract
In the randomized trial AML-BFM 93 we compared 60 mg/m2/day daunorubicin with 12 mg/m2/day idarubicin for 3 days each, combined with cytarabine and etoposide during induction. Results showed a significant better blast cell reduction in the bone marrow on day 15 in patients of the idarubicin arm (25 of 144 = 17% of patients with ⩾5% blasts compared to 46 of 149 = 31% of patients after daunorubicin, Pχ2 = 0.01). This was, however, mainly seen in high risk patients treated with idarubicin (19% vs 38%, Pχ2 = 0.007). Cardiotoxicity, WHO grade 1–3 shortening fraction reduction after induction occurred in 6% patients in both arms. Bone marrow toxicity differed slightly with a median recovery time of neutrophils >500/μl of 25 days (daunorubicin) compared to 27 days (idarubicin), P = 0.05. In the total group of patients probabilities of 5 years event-free survival and disease-free survival were similar for patients treated with daunorubicin or idarubicin (49% ± 4% vs 55% ± 4% and 57% ± 4% vs 64% ± 4%, P logrank 0.29 and 0.15, respectively). However, in patients presenting with more than 5% blasts on day 15 there was a trend for a better outcome after treatment with idarubicin (P logrank 0.06). Together with the early effect seen for high risk patients these results indicate a better efficacy of idarubicin than of daunorubicin during induction with a similar rate of toxicity.
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Acknowledgements
We thank P Stappert, E Kurzknabe and J Meltzer for excellent technical assistance and Christa Lausch for her valuable assistance in the management of the AML studies. This study was supported by the Deutsche Krebshilfe.
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Principal investigators of Study AML-BFM 93 in Germany
Principal investigators of Study AML-BFM 93 in Germany
R Mertens, Kinderklinik RWTH, Aachen; A Gnekow, I. Kinderklinik des Klinikums, Augsburg; GF Wündisch, Universitäts-Kinderklinik, Bayreuth; G Henze, CCVK-Kinderklinik Berlin; E Hilgenfeld, Charité-Kinderklinik; W Dörffel, II. Kinderklinik Berlin-Buch; N Jorch Kinderklinik Gilead Bielefeld, U Bode, Universitäts-Kinderklinik, Bonn; H-J Spaar/Th Lieber Prof Hess-Kinderklinik, Bremen; W Eberl, Städtische Kinderklinik, Braunschweig; I Krause, Städtische Kinderklinik Chemnitz; E Holfeld, Kinderklinik d Carl-Thiem-Klinikums Cottbus; W Andler/Th Wiesel, Vestische Kinderklinik, Datteln; I Lauterbach, Kinderklinik d TU Dresden; V Scharfe, Städtische Kinderklinik Dresden-Neustadt; G Weinmann, Universitäts-Kinderklinik Erfurt; JD Beck, Universitäts-Kinderklinik, Erlangen; W Havers Universitäts-Kinderklinik, Essen; B Kornhuber, Universitäts-Kinderklinik, Frankfurt; CM Niemeyer, Universitäts-Kinderklinik Freiburg; A Reiter/R Blütters-Sawatzki, Universitäts-Kinderklinik, Gieβen; M Lakomek/A Pekrun, Universitäts-Kinderklinik, Göttingen; JF Beck/H Weigel, Universitäts-Kinderklinik Greifswald; V Gerein Kinderklinik Gummersbach, S Burdach/T Rieβ, Universitäts-Kinderklinik Halle; H Kabisch/R Schneppenheim, Universitäts-Kinderklinik Hamburg; B Selle, Universitäts-Kinderklinik, Heidelberg; N Graf, Universitäts-Kinderklinik Homburg/Saar; J Hermann, Universitäts-Kinderklinik Jena; G Nessler, Städtische Kinderklinik, Karlsruhe; Th Wehinger, Städt Kinderklinik, Kassel; M Rister, Kinderklinik Kemperhof, Koblenz; F Berthold, Universitäts-Kinderklinik, Köln; W Sternschulte, Städtisches Kinderkrankenhaus, Köln; M Suttorp, Universitäts-Kinderklinik, Kiel; D Körholz/K Rieske, Universitäts-Kinderklinik Leipzig; P Bucsky, Universitäts-Kinderklinik, Lübeck; HCh Dominick Kinderklinik St Annastift Ludwigshafen, U Kluba, Universitäts-Kinderklinik Magdeburg; W Scheurlen, Städt Kinderklinik, Mannheim; P Gutjahr, Universitäts-Kinderklinik, Mainz; H Christiansen, Universitäts-Kinderklinik, Marburg; RJ Haas, v Haunersches Kinderspital, München; St Müller-Weihrich/L Stengel-Rutkowski, Kinderklinik der Technischen Universität, München-Schwabing; Ch Bender-Götze/M Führer, Universitäts-Kinderpoliklinik, München; H Jürgens, Universitäts-Kinderklinik, Münster; A Jobke, Cnopfsche Kinderklinik, Nürnberg; U Schwarzer, Städtische Kinderklinik, Nürnberg; G Eggers/M Hagen, Universitäts-Kinderklinik Rostock; R Schumacher, Kinderklinik Schwerin; R Dickerhoff, Johanniter Kinderklinik, St Augustin; J Treuner, Olgahospital, Stuttgart; D Niethammer/T Klingebiel, Universitäts-Kinderklinik Tübingen; W Behnisch, Universitäts-Kinderklinik, Ulm; J Kühl, Universitäts-Kinderklinik, Würzburg.
Principal investigators of Austria
C Urban, Universitäts-Kinderklinik d Landeskrankenhauses Graz; FM Fink, Universitäts-Kinderklinik d Aö Landeskrankenhauses Innsbruck; K Schmitt/G Ebetsberger Landes-Kinderkrankenhaus Linz; I Slavc AKH-Universitäts-Kinderklinik Wien; H Gadner St Anna-Kinderspital Wien
Principal investigators of Switzerland
P Imbach, Kinderklinik d Kantonsspital Aarau; PA Avoledo Universitäts-Kinderspital Basel; A Feldges Ostschweizerisches Kinderspital St Gallen; M Nenadov-Beck/C Desseng CHUV-Kinderklinik Lausanne; U Caflisch Kinderspital Luzern; L Nobile Buetti Kinderklinik Hospital La Carita Locarno; F Niggli/Universitäts-Kinderklinik Zürich
The coordinators of study AML-BFM 93
J Ritter, U Creutzig, J Hermann, H Gadner, Universitäts-Kinderklinik, Münster, Jena und St Anna Kinderspital Wien
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Creutzig, U., Ritter, J., Zimmermann, M. et al. Idarubicin improves blast cell clearance during induction therapy in children with AML: results of study AML-BFM 93. Leukemia 15, 348–354 (2001). https://doi.org/10.1038/sj.leu.2402046
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DOI: https://doi.org/10.1038/sj.leu.2402046
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